Active Pharmaceutical Ingredients Market Expected to Reach US$ 21.9 Bn Globally in 2023
According to a new market report published by Transparency Market Research “Active Pharmaceutical Ingredient Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 – 2023” the global active pharmaceutical ingredient market for was valued at US$ 12.9 bn in 2014 and is estimated to reach US$ 21.9 billion by 2023 at a CAGR of 6.3% from 2015 to 2023.
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An active pharmaceutical ingredient is the ingredient in a pharmaceutical drug that is biologically active. Demand for low cost medicines and increasing number of ANDA filings are fuelling the growth of the global active pharmaceutical ingredients market.
The active pharmaceutical ingredient market is categorized into manufacturing process, type of API, drug type and therapeutic areas. The API manufacturers include those for captive or in-house API and contract API. Captive API manufacturing refers to production of the active pharmaceutical ingredients for internal consumption of a pharmaceutical company. Contract manufacturing involves outsourcing of API manufacturing by the innovator/formulator company to CMOs. Captive manufacturing also known as in-house manufacturing held the largest share of the global active pharmaceutical ingredient market in 2014. However, the market of captive manufacturing is declining due to high production cost and limited for the manufacturing niche APIs that offer high operating profit margins or for companies that are into generics and have their own formulation plants.
The adoption rate of contract manufacturing is increasing due to soaring R&D costs and pricing pressure on finished products. Improving quality and time-to-market, along with reduction in fixed costs are the other important factors propelling the growth of the API contract manufacturing segment. Outsourcing of API production to countries such as India and China have introduced innovative production processes and advanced manufacturing technologies to remain competitive in the market.
The synthetic chemical API segment had the largest share of this market in 2014 and has evolved in the past few years due to innovations in the methods of synthesizing chemical APIs, which improves their stability and potency., Whereas, the market for biological API is expected to have the highest growth rate in the forecast period of 2015 to 2023. The global API market is transforming, as large pharmaceutical companies are shifting focus toward the biological APIs segment. Protein-based therapeutics (peptides, proteins, enzymes and antibodies) have emerged as a major growth engine in the biological API market. Apart from the currently marketed blockbuster biologics such as Humira and Herceptin, several other promising biologics such as mepolizumab (GSK), dupilumab (Sanofi/Regeron), alirocumab (Sanofi), evolocumab (Amgen), brodalumab (Amgen), ixekizumab (Eli Lilly) and secukinumab (Novartis) are expected to enter several geographical markets during the forecast period from 2015 to 2023. This factor has attracted higher investments in the biologics and biosimilars market.
Based on the drug type, the global API market is segmented into branded prescription drugs, generic prescription drugs and OTC drugs. The branded API segment accounted for the largest share of the global API market in 2014. According to the USFDA, 44% of the pharmaceutical products launched in the U.S. between 2007 and 2012 were new molecules. This reflected the frequency of novel molecules entering in the market. Increasing demand for new treatments will certainly increase the branded API market in the near future. The generic prescription drugs segment is expected to grow at the highest rate in the forecast period owing to their low cost. Currently, the major pharmaceutical companies are also focusing on generic drugs along with branded drugs due to eroding product pipeline and patent expirations. Over-the-counter (drugs) are considered sufficiently safe and effective and increasing access to these medicines through expansion of distribution channels would further drive this market during the forecast period.
The global API market categorizes therapeutics areas segment into different disorders such as cardiovascular, metabolic, neurological, oncology, musculoskeletal, non-steroidal anti-inflammatory drugs (NSAIDs), and other therapeutic uses. Cardiovascular, metabolic, and neurological disorders together held the largest share of more than 50% in 2014.